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February 2025
The global single-use bioreactors market size is calculated at US$ 4.59 in 2024, will grow to US$ 5.38 billion in 2025, and is projected to reach around US$ 22.46 billion by 2034. The market is expanding at a CAGR of 17.21% between 2025 and 2034. The growing demand for cell therapies and personalized medicine is contributing to the growth of the single-use bioreactors market.
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When a culture vessel is replaced with a disposable bag, the bioreactor is referred to as a single-use or disposable bioreactor. A relatively new invention, disposable bioreactors are becoming more and more popular for use in cell and microbial growth. Their benefits include lower personnel expenses, no cleaning or cleaning validation, convenience of use, quick deployment, flexibility of operation, and fewer utility requirements like water and steam. According to some estimations, single-use systems can save over 60% more money than fixed-asset stainless steel bioreactors. Conventional bioreactors are being quickly replaced with single-use bioreactors, which are widely employed in the area of mammalian cell culture.
Numerous sectors are becoming more contemporary because of advancements in automation and regulated monitoring. The automation and extensive use of diagnostic sensors in bioreactors have also increased their efficiency and consistency, resulting in quicker speed-to-market and better product yields. In order to improve the performance of bioprocessing systems and accelerate the manufacture of biopharma products, technologies like as artificial intelligence (AI) and machine learning (ML) are implemented in bioreactors.
Growing Demand for Biopharmaceuticals
The growing markets for vaccines, monoclonal antibodies, and other biomolecules have contributed to a significant increase in the demand for biologics worldwide in recent years. Scaling up biomanufacturing capabilities is becoming more and more important as biopharmaceutical pipelines continue to produce potential novel medication ideas. However, constructing more stainless-steel factories might take two to three years and involve significant capital expenditures. Single-use bioreactors, on the other hand, offer a quicker and more affordable way to speed up bioproduction without requiring a large facility expansion. By putting them into practice, it will be possible to quickly acquire the necessary biomanufacturing capacity to better meet market demands.
Scalability Limitations
It can be difficult to scale up the manufacturing of biopharmaceuticals utilizing single-use bioreactors. To maintain consistency while scaling from small-scale to large-scale manufacturing, process parameters, and system architecture must be carefully optimized. Single-use bioreactors usually have a smaller working volume than conventional stainless-steel bioreactors. The production capacity may be limited by this restriction, particularly for the large-scale manufacture of biopharmaceuticals.
Focus on Sustainable Practices
The single-use bioreactors market is being positively impacted by sustainable production techniques. Waste reduction and improving the recyclability of bioprocessing materials are priorities as environmental concerns increase. In order to minimize their impact on the environment, single-use devices are being developed with recyclable components. For example, several manufacturers are looking into recycling possibilities for discarded bioreactor components and employing biodegradable polymers.
By product, the single-use bioreactor systems segment dominated the single-use bioreactors market in 2024. systems for single-use bioreactors (S.U.B. designed to increase speed-to-market, scalability, and sustainability using technology that has been proven in the industry. A wide range of cell lines and processing methods may be accommodated by the flexible array of S.U.B.s, which facilitates robust production across sizes.
By product, the single-use media bags segment is estimated to grow at a significant rate in the single-use bioreactors market during the forecast period. Single-use bioprocess bags offer a simplified method of increasing production efficiency. A single-use bioprocess bag is strong, long-lasting, and resistant to temperature, making it suitable for handling by both humans and machines using specialist pharmaceutical equipment. Bioprocess bags are made to hold reactions made up of sterile medium, cell cultures, sera, buffers, and reagents. They are available in a range of sizes.
By type, the stirred tank SUBs segment led the single-use bioreactors market in 2024 and is estimated to grow at the fastest rate during the forecast period. Stirred tank reactors, or STRs, are among the most common types of bioreactors. STRs are widely utilized because of their benefits, which include fast scale-up, good fluid mixing, and oxygen transfer capabilities, different impellers, and simple compliance with cGMP criteria. The creation and subsequent advancements of single-use stirred bioreactors have provided a more adaptable and economical substitute for its stationary stainless steel equivalents. Stirred bioreactors for single use have a number of benefits that make them a desirable choice for flexible facility design.
By type of cell, the mammalian cells segment dominated the single-use bioreactors market in 2024. due to the crucial part mammalian cells play in the production of complicated biologics such as recombinant proteins, vaccines, and monoclonal antibodies. These cells are essential for the expression of proteins that have the proper folding, assembly, and post-translational modifications needed for both therapeutic safety and effectiveness. Conventional bioreactors are being quickly replaced with single-use bioreactors, which are widely employed in the area of mammalian cell culture. A disposable bag is used in a single-use bioreactor in place of a glass or stainless steel culture vessel.
By cell type, the bacterial cells segment is estimated to grow at a significant rate in the single-use bioreactors market during the forecast period. Pharmaceuticals and biotechnology both heavily rely on microbial fermentation. Applications include the creation of plasmids, recombinant proteins, and vaccinations, to name just a few. There is a great need for single-use bioreactors that can support more demanding fermentation processes because single-use technology is not only very beneficial for cell culture processes but also evidently for microbial fermentation processes, such as in seed trains, process development, and small-scale production.
By molecule type, the vaccines segment held the major share of the single-use bioreactors market in 2024. In the current vaccination environment, single-use technologies are a revolutionary production method that is being embraced by vaccine producers more and more. There is a significant market need for vaccinations at the moment, such as those for measles, rabies, and DPT. The solution to the vaccine manufacturing capacity issue lies in increasing the production process's efficiency.
By molecule type, the gene modified cells segment is estimated to grow at the fastest rate in the single-use bioreactors market during the forecast period. There is now more hope for these eagerly awaited "drugs" of the future, thanks to advancements in the therapeutic effectiveness of gene-modified cell treatments across a range of preclinical models and clinical studies. Thanks to developments in genetic engineering, scientists can now more easily create these therapeutic cells, which will enable their broader use, more precise development, and, eventually, a larger range of applications. The rapidly developing area of gene-modified cells for the treatment of many malignant and non-malignant illnesses is highlighted in this special cytotherapy issue.
By application, the research and development (R&D) or process development segment held the largest share of the single-use bioreactors market in 2024. Global organizations and large corporations are boosting their investments in biopharmaceutical research and development projects because of the growing potential. The biopharmaceutical business makes a far greater contribution to research and development than other assembling endeavors. For the production of biopharmaceutical components, single-use bioreactors are essential. They comprise a significant portion of small and mid-sized biopharmaceutical production, particularly in novel work and clinical testing.
By application, the bioproduction segment is anticipated to be the fastest-growing in the single-use bioreactors market during the predicted time frame. The utilization of live cells or creatures to create usable goods, known as bioproduction, has grown in popularity across a variety of sectors because it can provide high-value products at a cheaper cost. The ability to produce biological products and chemicals from live cells that are both therapeutically and financially significant is essential to the wide bioeconomy's potential.
By usage, the lab-scale production segment dominated the single-use bioreactors market in 2024. Laboratory scales are essential instruments where precision and accuracy are crucial. Because laboratory-scale studies don't require as much infrastructure and facilities and utilize fewer amounts of materials and equipment, they are usually less expensive to undertake than full-scale investigations. Researchers can learn more about the basic ideas behind a process or technology through laboratory-scale experiments, which can serve as a basis for further investigation and advancement.
By usage, the large-scale production segment is estimated to achieve significant growth in the single-use bioreactors market during the forecast period. To build cost-effective capacity to satisfy the growing demand for antibodies and other biotherapies, scale-up solutions are required. Demand is the main factor driving market pressure for the continued use of large-scale SUBs. Significantly, contract development and manufacturing organizations (CDMOs) are able to keep their current clientele thanks to large-scale SUBs. Furthermore, compared to stainless-steel facilities, large-scale SUBs let firms boost their production throughput at a lower capital investment (CapEx).
By end-use, the CMOs & CROs segment led the single-use bioreactors market in 2024. Quick campaign switchovers and more flexible production capacity are often desired by CMOs. As a result, they employ a greater range of single-use components and systems. The increasing tendency of outsourcing has increased the usage of SUBs by CMOs and CROs. The efficiency and utility of SUBs in handling a range of biopharmaceutical products and changing market needs are credited with this development. Significant SUS device penetration and faster CMO acceptance of new SUS technology are the results of these factors.
By end-use, the pharmaceutical and biopharmaceutical companies segment is estimated to grow significantly in the single-use bioreactors market during the forecast period. The growth of this market is due to the expanding R&D activities of biopharmaceutical, biotechnology, and pharmaceutical companies, as well as the growing production of biologics and biosimilars. Additionally, the widespread usage of SUBs by biotechnology and pharmaceutical firms in developed and established countries, such as North America and Europe, as well as the increasing approvals of biologics and biosimilars in these regions, are the main factors propelling the expansion of this end-user sector.
North America dominated the single-use bioreactors market share by 35% in 2024 because of its substantial investments in biotechnology, sophisticated research infrastructure, and well-established biopharmaceutical sector. The strong demand for biologics and biosimilars, bolstered by a strong network of pharmaceutical businesses, contract manufacturing organizations, and research institutes, is what propels the region's supremacy. Furthermore, North America's market position is strengthened by its leadership in technology innovation and regulatory developments.
The global leader in biopharmaceutical research and development is Biopharmaceuticals. In 2023, biopharmaceutical companies in the United States spent around $96 billion on research and development, according to the Pharmaceutical Research and Manufacturers Association (PhRMA). More than 20 percent of overall revenues in 2023 came from R&D conducted by biopharmaceutical companies in the United States. The biopharmaceutical sector has a significant total economic influence on the US economy. In 2023, foreign direct investment in medications and pharmaceuticals came to $503.4 billion.
The substantial number of biopharmaceutical products in the pipeline and the fact that Canada leads the G7 in clinical trial productivity show that, in addition to its distinction in academia and science, Canada excels in the creation of intellectual property and clinical development capabilities.
Asia Pacific is estimated to host the fastest-growing single-use bioreactors market during the forecast period. Driven by growing biomanufacturing capabilities in emerging nations and a greater emphasis on healthcare innovations. With large expenditures in the production and development of biopharmaceuticals, nations like China and India are leading the way. The expansion of the regional market is supported by lower manufacturing costs, an increase in biotech firms, and a rise in the need for reasonably priced biologics. Favorable government regulations and incentives targeted at advancing the biotech industry further help the Asia Pacific market. The need for single-use bioreactors is anticipated to rise in the area as these nations continue to improve their research and production capacities.
The biotechnology industry in India has grown 13 times in the last ten years, from $10 billion in 2014 to nearly $130 billion in 2024. By 2030, it is expected to have grown to $300 billion. Metropolitan areas, Tier I cities, and rural markets, each of which has around 30% of the market share, are driving growth in the Indian pharmaceutical sector.
According to Arun Luthra, founder, and CEO of Amerging Technologies, one of the top producers of bioprocess equipment in India, automation is the key to consistent and efficient bioreactor operation. He claims that automation guarantees accuracy and repeatability at every level, in contrast to manual procedures, which are subject to human error and unpredictability. Increased output, less downtime, and eventually lower costs are all results of this dependability. Additionally, automation makes it easier to gather and analyze data, giving researchers access to real-time information on process parameters. Luthra claims that bioreactor operators may improve conditions, quickly resolve problems, and quicken the rate of scientific advancement by utilizing automated capabilities.
By Product
By Type
By Type of Cell
By Molecule Type
By Application
By Usage Type
By End-use
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February 2025
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